18 - 19 September 2019, Abu Dhabi, UAE

Day 2

Thursday: September 19, 2019

08:00  Registration and Refreshments
08:55 Opening Remarks by the Chairman

Prof. Gernod Dittel
CEO, Dittel Engineering
09:00 Cleanrooms Design and Construction: Stages and Typical Mistakes

• Key stages in design and construction
• Delivery of project from start to turnkey
• Cleanroom management in pharmaceuticals and healthcare

Hitesh Upreti
MD, Zenufa

09:30 Cleanroom Garments from a Quality Risk Management Perspective

• Understanding “people in cleanroom”
• Reviewing and resolving the major contamination factors
• Staff gowning and personnel behavior

Matts Ramstorp
BioTekPro, Sweden

10:00 ePTFE and eFRM membrane HEPA/ULPA filters for pharmaceutical and microelectronics application
  • ePTFE and eFRM membrane HEPA/ULPA filters, structure and media properties vs glass media
• validation of ePTFE and eFRM membrane HEPA/ULPA filters
• risk reduction, energy savings
• benefits of ePTFE and eFRM membrane HEPA/ULPA filters

Dr. Marc Schmidt
Director Research and Development – Europe, AAF International
10:30 Coffee and Networking 
11:00 GMP Annex 1: A new Dawn in Garment Selection
  • Understanding the impact of GMP Annex 1 on contamination control strategies
• Different garment systems and results of the DuPont study on reusable garments
• Value chain assessment

Jean-Francois Teneul
Global Life Sciences Market Leader – Personal Protection, DuPont de Nemours 
11:30 Sterile Compounding Program Elements: Quality Control and Best Practice 

Provides the necessary information and guidance, to assure the production of high-quality, compounded sterile preparations:
• Employee Education
• Compounding Process
• Quality Assurance

Dr. Nura Al Banyan
Lead Pharmacist, King Fahd Medical Centre 

12:00 Lab Cleanliness Assessment for Infection Prevention and Control
  • Check on microbial contaminants
• Limitations of sampling equipment
• Sterility assurance in environment monitoring

Dr. Najiba Abdul Razzaq
Head of Infection Control, Ministry of Health, UAE
12:20 Interactive Panel Discussion
13:00 Prayer and Lunch Break
14:00  Containment Room Applications

• Sealing requirements in clean and contained Rooms
• Classic methods of sealing cable and pipe entries and the cost of failure
• Optimized cable and pipe sealing methods
• Case study
• Need for specifications on effective sealing methods

Mohammed Toubasi
Technical Manager, Roxtec



14:30  Is the IVF Industry Ready for Cleanroom Technology?

The talk will outline the special considerations that are paramount within a laboratory for successful embryo culture and high pregnancy rates with emphasis on laboratory environment and air quality. The current international standards and guidelines will be discussed and the need for the implementation of cleanroom technologies in the sector. 

• The IVF laboratory and its processes
• Air quality and the challenges of In Vitro Embryo culture
• Current standards and guidelines
• Future trends and developments

Giles Palmer
Business and Quality Manager, London Women's Clinic



 15:00 Microbiology in Cleanrooms and Isolators used for Sterility Testing
  • Regulatory Requirements
• State of the art Sterility Testing
• Qualification of Isolators
• Microbiological Monitoring
• Comparison Isolator vs. Cleanroom

Dr. Timo Krebsbach
Managing Director, HHAC Laboratory Heusler GmbH
 16:00 Closing Remarks and End of Cleanzone Middle East 2019